JP2019523088A - Tissue retraction device - Google Patents

Abstract

The present invention relates to the field of tissue resection. In particular, the present invention relates to a medical device that lifts and retracts tissue during ablation to improve the visibility of the target tissue and prevent the ablation instrument from being disturbed. More particularly, the present invention relates to a tissue retraction device that moves from a constrained posture to a relaxed posture and retracts the resectioned portion of the target tissue without moving during the resection.

Description

  The present invention relates to the field of tissue resection. Specifically, it relates to a medical device that lifts and retracts tissue during ablation surgery so as to improve visualization of the target tissue and not interfere with the ablation instrument. More particularly, the present invention relates to a tissue retractor that moves from a constrained position to a relaxed position during resection surgery to retract the resected portion of the target tissue without moving it.

  Since it is difficult to visualize the target tissue during resection surgery, surgical resection of a lesion from a narrow body passage such as the digestive system can be inefficient and time consuming. This problem is exacerbated because the target tissue partially excised during the operation blocks the work site, further reducing visibility and obstructing the ablation instrument.

In some aspects, the present invention relates to a tissue retraction device that retracts a target tissue without movement during resection to improve tissue visibility and operability.
In one aspect, the invention includes a proximal end configured to engage a first target tissue portion, a distal end configured to engage a second target tissue portion, With respect to a tissue retraction device comprising an elongate flexible element comprising at least one guide member secured to the flexible element, the at least one guide member forms a lumen extending therethrough. The elongate flexible member moves between a first posture (restricted, constrained, contained, or transported posture) and a second posture (relaxed, free, or deployed posture).

  In another aspect, the invention provides a proximal end configured to engage a first target tissue portion, a distal end configured to engage a second target tissue portion, and an elongated shape. A tissue retractor comprising an elongate flexible element with at least one guide member secured to the flexible element, the at least one guide member forming a lumen extending therethrough, and at least A control wire is slidably received within the lumen of one guide member, and the elongate flexible element has the control wire disposed within the lumen of at least one guide member. The first posture (restricted, restrained, contained, or transport posture) and the second posture when the control wire is not disposed inside the lumen of at least one guide member (relaxed, free, or deployed posture) ). The at least one guide member comprises a plurality of guide members fixed along the length of the elongate flexible element. The end of at least one guide member comprises a cap. The elongate flexible element is substantially flat when in the first position. The elongate flexible element is curved along the major axis in the second posture. The elongate flexible element can comprise a woven mesh. Additionally or alternatively, the elongate flexible element consists of a plurality of parallel elements. The plurality of parallel elements may be secured to each other by at least one or more guide members. A portion of the parallel element curves outward from the long axis of the elongate flexible element. The control wire passes between the parallel elements when positioned within the lumen of the at least one guide member. The proximal and distal ends of the elongate flexible element may include one or more tissue anchors, such as tines, forks, hooks, fingers, barbs, loops, and / or clips. Prepare. Additionally or alternatively, one or more stabilizers such as hooks and / or barbs are secured to the elongate flexible element. The elongate flexible element is formed from a polymer such as, but not limited to, an acrylate-based polymer, a polyurethane-based polymer, a polynorbornene-based polymer, a polylactide-based polymer. Additionally or alternatively, the elongate flexible element may be a metal such as, but not limited to, platinum, tungsten, titanium, stainless steel, nickel, nickel-titanium alloys, and alloys described above or other metals. Or it forms from a metal alloy.

  In another aspect, the present application relates to a system comprising a delivery catheter and an elongate flexible element slidably received within the lumen of the delivery catheter. The elongate flexible element has a proximal end configured to engage a first target tissue portion, a distal end configured to engage a second target tissue portion, and an elongate shape. At least one guide member secured to the flexible element and the at least one guide member form a lumen extending therethrough and slidably received within the lumen of the at least one guide member. A control member to be received. The elongate flexible element has at least one control position when the control element is disposed within the lumen of at least one guide member (constrained, restricted, contained, or transported position) and at least one When the guide member is not disposed inside the lumen, the guide member moves between the second posture (relaxed, free, or deployed posture). The proximal end of the control wire extends beyond the end of the delivery catheter. The delivery catheter is slidably received within the working channel of the endoscope. Additionally or alternatively, the at least one guide member is secured along the length of the elongate flexible element.

  In yet another aspect, the present invention advances the delivery catheter past the working channel of the endoscope to a location near the target tissue such that the distal end of the delivery catheter is over the first portion of the target tissue. The working channel of the delivery catheter includes a proximal end configured to engage the first target tissue portion and a distal end configured to engage the second target tissue portion. And at least one guide member fixed to the elongated flexible element, the at least one guide member forms a lumen penetrating the interior, and at least one A control wire slidably received within the lumen of one guide member, wherein the elongate flexible element is disposed within the lumen of the at least one guide member. The first posture when Moving between the second position when not positioned within the lumen of the at least one guide member and the elongate flexible element beyond the distal end of the delivery catheter Advancing the control wire distally to engage the first portion and the delivery catheter closer so that the proximal end of the elongate flexible element moves beyond the distal end of the delivery catheter; Retracting in a lateral direction and the proximal end of the elongate flexible element relative to the proximal end of the elongate flexible element such that the proximal end of the elongate flexible element engages the second portion of the target tissue. Moving the distal end and retracting the control wire proximally such that the control wire is removed from within the lumen of the at least one guide member. The method includes advancing a tissue removal element, such as ablation, through the working channel of the endoscope, and the target tissue when the elongate flexible element is moved from the first position to the second position. Cutting along the perimeter.

  Non-limiting examples of the present invention have been described by way of example with reference to the accompanying drawings. The drawings are schematic and are not intended to be drawn to scale. In the drawings, identical or practically identical components shown are generally indicated by a single numeral. For the sake of brevity, not all elements are numbered in the drawings and all embodiments of the present invention are not necessarily numbered in the drawings unless necessary to enable the person skilled in the art to understand the invention. The components of are not shown.

The figure which shows the structure | tissue retraction apparatus of the restraint carrier posture which concerns on embodiment of this invention. The figure which shows the structure | tissue retraction apparatus of the relaxation curve attitude | position which concerns on embodiment of this invention. FIG. 3 shows a tissue anchor element that can be placed at both ends of a tissue retractor according to an embodiment of the invention. FIG. 3 shows a tissue anchor element that can be placed at both ends of a tissue retractor according to an embodiment of the invention. FIG. 3 shows a tissue anchor element that can be placed at both ends of a tissue retractor according to an embodiment of the invention. FIG. 3 shows a tissue anchor element that can be placed at both ends of a tissue retractor according to an embodiment of the invention. The figure which shows the tissue stabilizer arrange | positioned at the lower surface of the tissue retraction apparatus which concerns on embodiment of this invention. The figure which shows a part of tissue retraction apparatus of the parallel attitude | position which concerns on embodiment of this invention. The figure which shows a part of the structure | tissue retraction apparatus of the curvature posture which concerns on embodiment of this invention. 1B is a diagram showing the tissue retraction device of FIG. 1A disposed inside a lumen of a delivery system according to an embodiment of the present invention. FIG. The figure which shows the method of arrange | positioning the tissue retraction apparatus on the target tissue which concerns on embodiment of this invention. The figure which shows the method of arrange | positioning the tissue retraction apparatus on the target tissue which concerns on embodiment of this invention. The figure which shows the method of arrange | positioning the tissue retraction apparatus on the target tissue which concerns on embodiment of this invention. The figure which shows the method of arrange | positioning the tissue retraction apparatus on the target tissue which concerns on embodiment of this invention. The figure which shows the cutting | disconnection of the target tissue using the tissue retraction apparatus which concerns on embodiment of this invention. The figure which shows the cutting | disconnection of the target tissue using the tissue retraction apparatus which concerns on embodiment of this invention. The figure which shows the cutting | disconnection of the target tissue using the tissue retraction apparatus which concerns on embodiment of this invention. The figure which shows the tissue retraction apparatus of the restraint flat attitude | position which concerns on another embodiment of this invention. The figure which shows the structure | tissue retraction apparatus of the relaxation curve attitude | position which concerns on embodiment of this invention. FIG. 3 shows two tissue retraction devices disposed along opposing planes of a target tissue according to an embodiment of the present invention. The figure which shows the tissue retraction apparatus of the restraint attitude | position which concerns on another embodiment of this invention. The figure which shows the tissue retraction apparatus of the relaxation posture which concerns on another embodiment of this invention. The figure which shows the tissue retraction apparatus of the restraint attitude | position which concerns on another embodiment of this invention. The figure which shows the tissue retraction apparatus of the relaxation posture which concerns on another embodiment of this invention. The figure which shows the structure | tissue retraction apparatus of the conveyance attitude | position which concerns on another embodiment of this invention. The figure which shows the tissue retraction apparatus of the restraint attitude | position which concerns on another embodiment of this invention. The figure which shows the tissue retraction apparatus of the relaxation posture which concerns on another embodiment of this invention.

  It should be noted that the drawings are intended to describe general or exemplary embodiments of the invention. Accordingly, the drawings should not be taken as limiting the scope of the invention. The present invention will be described in more detail below with reference to the accompanying drawings.

  Before describing the invention in further detail, it is to be understood that the invention is not limited to the specific embodiments described, and that various embodiments are possible. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Finally, embodiments of the present application have been described with particular reference to medical devices and systems for excising digestive system tissue, but medical devices can be used for tissues such as the abdominal cavity, gastrointestinal tract, and thoracic cavity. It must be understood that it can also be used for excision. In addition, various medical procedures such as endoscopic submucosal resection (ESD), oral endoscopic myotomy (POEM), cholecystectomy, video assisted thoracoscopic surgery (VATS) are disclosed herein. It is possible to benefit from existing medical devices.

  As used herein, the term “distal” refers to the end furthest away from the health care worker when the device is inserted into the patient's body, and the term “proximal” The end closest to the health care worker when the medical device is inserted into the patient's body.

  The term “tissue retraction” or “retraction” as used herein refers to the ability to control the position of the tissue during resection. For example, “retraction” means that the excised element of the target tissue is lifted from the excision surface to make it easier to see by lifting it from the remaining part of the target tissue (non-excised part) while keeping the excised part of the target tissue unmovable and more accurately This means that tension is applied to the target tissue in order to perform the operation.

  As used herein, the term “target tissue” means a portion of tissue that is unhealthy or diseased (cancerous, precancerous) or undesired. “Target tissue” includes tissues that are unhealthy or suspected of having lesions, but the state of such tissues needs to be surgically removed to confirm the pathological condition by biopsy. Surgical excision of the “target tissue” ensures that everything is removed and minimizes the chance that left or unremoved “target tissue” cells will metastasize to other parts of the body It should be understood that this generally involves removal of the healthy tissue portion around the “target tissue”.

  In one embodiment, the present invention allows the ablated target tissue portion to be retracted and not moved, such as preventing the endoscopic working channel from being closed or blocked, during resection. Provide a tissue retraction device that improves the visibility and accessibility of the target tissue. As shown in FIGS. 1A-1B, in one embodiment, the present tissue retraction device includes a proximal end 112 configured to engage a first target tissue portion, and a second target tissue portion. An elongate flexible element 110 comprising a distal end 114 configured to engage, a first surface 116 (upper surface or upper surface), and a second surface 118 (lower surface or lower surface). (E.g. spine). The plurality of guide members 130 are arranged along the length of the elongated flexible element 110. 1A-1B are equally spaced along the second surface 118 of the elongate flexible element 110, the guide members are first and second in a uniform or non-uniform pattern. It can be placed on one of the surfaces 116, 118. Alternatively, the guide member may be tangential or flush with either one of the first or second surfaces 116, 118 of the elongate flexible element 110. In addition, the elongate flexible element 110 shown in FIGS. 1A-1B includes five guide members 130, but the number of guide members 130 is five or less (e.g., four or It should be understood that it may be less) or 5 or more (eg, 6 or more). Although shown in a circular shape, the guide member can take any various shapes in cross section, such as a semi-circle, an oval, a quadrangle, a rectangle, and the like. The elongate flexible element may have various lengths (eg, about 6 inches (1 inch = 2.54 centimeters), about 5 inches, about 4 inches, about 3 inches, about 2.75. Inches, about 2.0 inches, about 1.5 inches, about 1.0 inches, etc.). Each guide member 130 forms a lumen 132 extending therethrough. In one embodiment, the most distal end of the guide member 130 (the guide member closest to the distal end 114 of the elongate flexible element 110) comprises a cap 134. In one embodiment, the elongate flexible element 110 comprises parallel elements or wires 126a, 126b that are connected to each other by a plurality of guide members 130. The tissue retraction device further comprises a control wire 140 (eg, a mandrel for pressing) that is slidably received in a corresponding lumen 132 of each guide member 130 along the long axis of the elongate flexible element 110. obtain. Referring to FIG. 1A, when the control wire 140 is placed inside the lumen 132 of each guide member 130, the elongate flexible element 110 is in a first orientation (restricted, restrained, contained, or transported). ). With reference to FIG. 1B, when the control wire 140 is not disposed within the lumen 132 of each guide member 130 (removed), the elongate flexible element 110 is in the second position (relaxed, free, or Move to the deployed position.

  In the first orientation, the elongate flexible element 110 has a flat or planar orientation such that substantially all of the second surface 118 is disposed against the tissue surface. In one embodiment, the elongate flexible element 110 comprises a width and a thickness such that the elongate flexible element 110 does not roll up or twist during the resection. It exceeds. For example, the elongate flexible element may have a thickness (eg, about 0.04 inch (1 inch = 2.54 cm), about 0.035 inch, about 0.030 inch, about 0.025 inch, Greater than about 0.020 inches) (e.g., about 0.070 inches, about 0.065 inches, about 0.060 inches, about 0.055 inches, about 0.050 inches), in some cases The width is about twice as large as the thickness. The elongate flexible element 110 is based on, for example, metals and metal alloys such as platinum, tungsten, titanium, stainless steel, nickel and nickel-titanium alloys (eg, Nitinol), polymers based on acrylates, polyurethanes and the like. Can be formed from a variety of elastic biocompatible materials, including polymers such as polymers based on polynorbornene, and polymers based on polylactide, and any combination thereof.

  When in a restricted position, due to the "force" stored within the material, the elongate flexible element 110 holds the embedded tissue under a certain pressure that lifts or retracts upward. can do. Curves from the flat or planar shape of the first posture to the second posture (eg, rounded or hemispherical) so that the portion of the target tissue to be excised can be more easily viewed and more efficiently excised. Due to the nature of the elongate flexible element 110 that moves into shape, the resected portion of the target tissue can be lifted or raised above the cutting surface. The shape of the second orientation can be controlled during operation to impart or set a desired memory on the material of the elongated flexible element that assumes a relaxed or unconstrained orientation.

  2A-2D, the proximal and distal ends 112, 114 of the elongate flexible element 110 indicate that the elongate flexible element 110 has detached from the tissue surface before the resection is complete. Non-limiting examples to prevent, for example, wire protrusions or tines (FIG. 2A), wire forks, fingers or hooks (FIG. 2B), wire ends (FIG. 2C) and / or loops, Various anchor postures may be provided, such as clips or barbs (FIG. 2D). Additionally or alternatively, the proximal and distal ends 112, 114 preferably comprise sharp or pointed tips to facilitate tissue penetration. In one embodiment, these (and other) wire anchor elements are made of a shape memory material such as Nitinol and are set by heat to direct downward when deployed, but are transported prior to deployment. It is constrained to a straight posture inside the catheter. When implanted within the target tissue, the proximal and distal ends 112, 114 simultaneously drive or push the second surface 118 of the elongate flexible element 110 downwardly relative to the target tissue surface. A force is generated in the target tissue that retracts upward (eg, lifts) and outward (eg, in the longitudinal direction).

  In FIG. 3, in one embodiment, one or more guide members 330 having one or more ballasts 325 (eg, hooks, barbs, etc.) secured to the second surface 318 of the elongate flexible element 410. And extend outwardly therefrom. Due to the pressure applied along the second surface 318 of the elongate flexible element 310 against the target tissue, the stabilizer 325 causes a portion of the target tissue between the proximal and distal ends 312, 314. Can be engaged. The additional tissue engagement provided by the stabilizer 325 provides additional retracting force to the target tissue and further allows the elongate flexible element 310 to roll back and twist during the resection. Can be prevented or minimized.

  4A-4B, in one embodiment, portions of wires 426a and 426b that are parallel between one or more guide members 430 are spread outwardly after placing elongate flexible element 410 or Provide one or more portions that have collapsed and have increased surface area to provide additional stability (such as rollback or torsional resistance). For example, one or more portions of the parallel wires 426a, 426b have a linear shape (FIG. 4A) when constrained, and are heat treated during the manufacturing process so as to fall outward (FIG. 4B) when exiting the transfer tube. Can do.

  In FIG. 5, in one embodiment, the present invention is elongately disposed in a lumen 556 of a delivery catheter 550 (eg, overtube, constraining sheath) slidably disposed in a first position (constrained). A transport system comprising a flexible element 510 is provided. Control wire 540 extends through lumen 556 of delivery catheter 550 such that the proximal end (not shown) of control wire 540 extends beyond the proximal end (not shown) of delivery catheter 550.

  In FIG. 6A, in use and in an exemplary manner, endoscope 660 is advanced through the body passageway such that distal end 664 of endoscope 660 is positioned proximate target tissue 72. A delivery system such as the catheter of FIG. 5 is then advanced through working channel 666 of endoscope 660 such that distal end 644 of delivery catheter 650 is positioned over the first portion of target tissue 72. Is done. The proximal end of the control wire is then advanced distally so that the distal end 614 of the elongate flexible element 610 moves beyond the distal end 654 of the delivery catheter 650. It should be understood that the cap 634 (FIG. 6B) of the distal most guide member 630 provides a surface on which the control wire 640 produces a distal force. The control wire 640 is advanced further distally to embed the distal end 614 of the elongate flexible element 610 within the first portion of the target tissue 72. Alternatively, the control wire secures the catheter or endoscope that has been advanced to embed the anchor in place. In one embodiment, the distal end 614 moves from a restrained position to a deployed position upon exiting the delivery catheter 650. Being in a deployed position provides a larger (wider) surface area for stronger engagement with the target tissue. In FIG. 6B, the delivery catheter 650 is positioned near the elongate flexible element 610 while a distal force is applied (maintained) to the elongate flexible element 610 by the control wire 640. To move the distal end 612 beyond the distal end 654 of the delivery catheter 650, it is retracted proximally. In FIG. 6C, the distal end 654 of the delivery catheter 650 is distal to the proximal end 612 of the elongate flexible element 610 to embed the proximal end 612 within the second portion of the target tissue 72. Advance to generate or apply lateral force. The distal force generated by the distal end 654 of the delivery catheter 650 against the proximal end 612 causes the elongate flexible element 610 to be placed before the proximal end 612 is implanted within the second portion of the target tissue 72. (Or in between) curved or inwardly bent. When the distal force imparted by the distal end 654 of the delivery catheter 650 is removed, the elongate flexible element 610 returns to an unbent posture and the first portion and second portion of the target tissue 72. The proximal and distal ends 612, 614 can be further pushed into and engaged, respectively, in the portion. Alternatively, if sufficient distal pressure is applied to the control wire, it is long enough to embed the anchor without engaging the elongated flexible element at the distal end of the delivery catheter. The flexible element can be curved. Additionally or alternatively, the anchor can be placed or implanted by itself with little or no distal pressure applied. In FIG. 6D, the control wire 640 is then retracted proximally from the interior of the lumen 632 of each guide member 630 and removed. When the control wire 640 is removed, the elongate flexible element 610 is further secured to the target tissue 72 due to its intrinsic tendency to move from its first position to its second position, so An upward and outward force is applied to the distal ends 612 and 614. There is also a pressure that simultaneously drives or pushes the second surface 618 of the elongate flexible element 610 against the surface of the target tissue 72. In order to minimize the possibility of leaving cancerous cells that can lead to metastasis, some surgical procedures involve the removal of healthy tissue portions (eg, non-lesional portions) outside or beyond the outer edge of the target tissue. It should be understood that it may be desirable to embed one or both of the proximal and distal ends 612, 614 therein. In such cases, the tissue is retracted only from the side of the elongate flexible element having an anchor embedded within the resected tissue.

  7A-7C, the ablation element 768 is then advanced through the working channel 766 of the endoscope 760 to ablate the target tissue 72 from the surrounding healthy tissue 70. When the target tissue 72 is excised, a part of the elongated flexible element 710 fixed to the lesion tissue moves from the first posture to the second posture, and the lesion is removed from the excision element 768 and the endoscope camera 769. The target tissue 72 is lifted and pulled. Once the target tissue has been completely excised, the elongate flexible element 710 and the target tissue 72 secured thereto can be used with an endoscope 760 using an appropriate grasping element (not shown) for biopsy. Through the working channel 766. Alternatively, the elongate flexible element 710 and the target tissue 72 secured thereto can be placed in a body passage for removal through the body's natural passage. Importantly, the elongate flexible element 710 does not occupy the working channel 766 of the endoscope 760 during the resection, so that the health care professional will have the additional care required for a given medical procedure. Medical instruments can be introduced and operated.

  In FIGS. 8A-8B, in one embodiment, the tissue retraction device of the present invention is an elongate flexible consisting of a mesh-like structure formed of polymers, metals, or alloys of various woven or interwoven shapes. Element 810 is provided. The proximal and distal ends 812, 814 of the elongate flexible element 810 are configured with a plurality of free ends configured to engage the first and second target tissue portions in a Velcro-like manner. A wire end 824 (eg, a wire tip) may be provided. In one embodiment, the surface of the elongate flexible element 810 can include one or more guide members that receive control wires (not shown). As described above, when the control wire is placed inside the central lumen (FIG. 8A), it holds the elongate flexible element 810 in the first position (constrained) and the central lumen (FIG. 8B). ), The elongate flexible element can be returned to the second position (relaxation). The elongate flexible element 810 can be placed in and on the target tissue using a delivery catheter and endoscope as described above.

  In FIG. 9, in one embodiment, one or more elongated flexible elements 910a, 9910b are disposed on the target tissue 72 to provide a plurality of tissue retraction planes. For example, the first elongate flexible element 910a is disposed along a first plane of the target tissue 72, and the second elongate flexible element 910b is arranged along a second plane of the target tissue 72. 1 is disposed orthogonally on the elongate flexible element 910a. Using multiple elongate flexible elements to allow multiple retracting planes to safely and efficiently ablate target tissue of at least one of large and irregular shapes Or, it can provide the delicate anatomy and the tissue retraction force required to ablate tissue around it.

  In FIG. 10A, in one embodiment, the tissue retraction device of the present invention comprises an elongate flexible element 1010 as described above and is radially outward from a central portion 1013 of the elongate flexible element 1010. First and second arms 1028a and 1028b (eg, strips, petals, legs, etc.) extending in the direction are further provided. The end 1029a of the first arm 1028a engages the third target tissue portion, and the end 1029b of the second arm 1028b engages the fourth target tissue portion. The plurality of guide members 1030 are disposed on a first surface 1016 (for example, an upper surface) including the first arm and the second arms 1028a and 1028b. Each guide member 1030 forms a lumen 1032 extending therethrough. In one embodiment, the end of the most distal guide member 1030 of the first and second arms 1028a, 1028b (the guide member closest to the ends 1029a, 1029b) is the surface on which the control wire produces a force distally. Is provided with a cap 1034. Finally, the tissue retracting device is slidably received in the lumen 1032 of each guide member 1030 disposed along the first surface 1016 comprising the first and second arms 1028a, 1028b, respectively. Second control wires 1040a and 1040b are further provided. For example, the first control wire 1040a extends along the first surface 1016 of the proximal portion 1017 of the elongate flexible element 1010 and bends at an angle of about 90 degrees at the central portion 1013 on the first arm 1028a. The guide member 1030 is slidably received in the lumen 1032. The second control wire 1040b extends along the first surface 1016 of the proximal portion 1017 of the elongate flexible element 1010 parallel to the first control wire 1040a and at an angle of about 90 degrees at the central portion 1013. It bends and is slidably received in the lumen 1032 of the guide member 1030 on the second arm 1028b. Although not shown in the figures, as shown in FIGS. 1A-1B, an additional control wire (third control wire) can be attached to the second surface 1018 (e.g., the bottom surface) of the elongate flexible element 1010. ) Can also be arranged. When the first and second control wires 1040a and 1040b are disposed inside the lumen 1032 of each guide member 1030, the first arm and the second arms 1028a and 1028b are held in the first posture (constrained). The With reference to FIG. 10B, when the first and second control wires 1040a, 1040b are not respectively placed (removed) within the lumen 1032 of each guide member 1030, the first and second arms 1028a, 1028b are second Move to posture (relaxation). When in a restrained position, the “force” stored within the material causes the elongate flexible element 1010 to lift or retract upward along multiple planes of the implanted target tissue. Can be applied and maintained.

  The tissue retraction device shown in FIG. 10B can be slidably disposed within the lumen of the delivery catheter described above. In one embodiment, the elongated flexible element 1010 portion of the tissue retraction device is placed on the target tissue according to the process described above. The first and second control wires 1040a, 1040b then have the first and second arms 1028a, 1028b outward so that the ends 1029a, 1029b engage the third and fourth tissue portions, respectively. It is advanced in the distal direction to form a planar posture (FIG. 10A). The arms of the elongate flexible element can be formed in a variety of shapes, and the ends 1029a, 1029b of each arm can have any tissue anchor configuration, for example as shown in FIGS. May be included.

  In FIG. 11A, in another embodiment, the tissue retractor of the present invention includes first and first radially extending from the distal portion 1115 of the elongate flexible element 1110 as shown in FIG. 1A. It further comprises two arms 1128a, 1128b and third and fourth arms 1128c, 1128d extending radially from the proximal portion 1117 of the elongate flexible element 1110. The end 1129a of the first arm 1128a engages the third target tissue portion, the end 1129b of the second arm 1128b engages the fourth target tissue portion, and the end 1129c of the third arm 1128c Engaging the fifth target tissue portion, the end 1129d of the fourth arm 1028d may engage the sixth target tissue portion. A plurality of guide members 1030 may be disposed along a first surface 1118 (upper surface) composed of the first, second, third, and fourth arms 1128a-d. Each guide member 1130 forms a lumen extending therethrough. In one embodiment, the distal-most guide member 1130 (the guide member closest to the ends 1129a-d) of each first, second, third, fourth arm 1028a-d allows the control wire to force distally. An end cap is provided to provide a surface that yields. Finally, the tissue retraction device is slidably received in the lumen of each guide member 1130 disposed along the first surface 1118 of the first, second, third, and 41128a-d. First, second, and third control wires 1140a, 1140b, and 1140c may be further provided. For example, the first control wire 1140a extends along the first surface 1118 of the elongate flexible element 1110 and is slidable into the lumen of the guide member 1130 on the first and second arms 1128a, 1128b. With a fork or split to be received. Alternatively, the first arm 1128a and the second arm 1128b of the elongate flexible element 1110 are provided with different or different control wires (not shown) so that they can be placed separately. The first control wire 1140b extends parallel to a portion of the first control wire 1140a and bends at an angle of 90 degrees or more at the proximal portion 1117 of the elongate flexible element 1110 so as to be on the third arm 1128c. The guide member 1130 is slidably received in the lumen of the guide member 1130. The third control wire 1140c extends parallel to a portion of the first control wire 1140a and bends at an angle of 90 degrees or more at the proximal portion 1117 of the elongate flexible element 1110 so as to be on the fourth arm 1128d. The guide member 1130 is slidably received in the lumen of the guide member 1130. Although not shown in the figures, for example, as shown in FIGS. 1A-1B, an additional control wire (fourth control wire) is provided on the second surface (lower surface) of the elongate flexible element 1110. Can be arranged along.

  When the first, second, and third control wires 1140a to 1140c are disposed inside the lumens of the guide members 1130, the first, second, third, and fourth arms 1128a to 1128d are It is held in a posture (constrained). In FIG. 11B, when the first, second, and third adjustment wires 1140a-c (not shown) are not disposed (removed) inside each guide member 1130, the first, second, The third and fourth arms 1128a to 1128d move to the second posture (relaxation). Additionally or alternatively, the distal and proximal arms along the long axis may be folded toward the second position when not constrained like the other arms. In FIG. 11C, in one embodiment, the first, second, third, and fourth arms 1128a-d are formed of a sufficiently flexible or deformable material so that the interior of the delivery catheter lumen. When constrained to, it can shrink inward along the elongate flexible element. When in a restrained position, the “force” stored within the material causes the elongate flexible element 1110 to lift or retract upward along multiple planes of the implanted target tissue. Can be applied and maintained.

  The tissue retraction device shown in FIG. 11C can be slidably disposed within the lumen of the delivery catheter as described above. In one embodiment, the portion of the elongate flexible element 1110 of the tissue retraction device is placed on the target tissue site according to the process described above. The first, second and third adjustment wires (not shown) are then directed outward so that the ends 1129a-d engage the third, fourth, fifth and sixth tissues, respectively. It is advanced in the distal direction to encourage the deployed position (FIG. 11A). The ends 1129a-d of each arm may comprise any tissue anchor configuration, as shown in FIGS.

  12A-12D, in one embodiment, the tissue retraction device of the present invention moves between a first position (constrained) (FIG. 12B) and a second position (relaxed, wound or reduced) (FIG. 12A). A sheet 1210 made of a shape memory material may be provided. A plurality of tissue anchors 1224 may be placed around the perimeter 1210a of the sheet 1210. Although the tissue anchors 1224 of FIGS. 12A-12B are disposed at substantially equal intervals along the perimeter 1210a of the sheet 1210, it should be understood that the tissue anchors may be disposed on the perimeter 1210a in an equal or non-uniform pattern. I must. The “force” stored within the shape memory material may provide and hold a constant pressure that lifts or retracts along multiple planes of the implanted target tissue. As shown in FIG. 12A, the sheet 1210 is wound in the first relaxed posture and the cylindrical posture, and is slidably disposed inside the lumen of the delivery catheter (not shown) and is restrained and transported. The Sheet 1210 is advanced distally beyond the distal end of the delivery catheter and deployed to the second restrained position of FIG. 12B so that tissue anchor 1224 can engage multiple portions of the target tissue. Become. Additionally or alternatively, a medical device (biopsy forceps) may be used to accurately place the sheet 1210 and apply sufficient pressure to engage at least some tissue anchors 1224 within the target tissue. , Advanced through the delivery catheter. When the sheet 1210 is fixed to the target tissue in the second posture (FIG. 12B), the central portion of the sheet 1210 is brought into contact with the medical device (pushing, hitting, striking), whereby the sheet 1210 has the first shape memory. It can be stimulated to return to posture (FIG. 12A), creating a pressure that lifts or retracts upward against the target tissue. It should be understood that the tissue retraction device described herein may comprise at least one arm and tissue anchor of any number, shape, size and orientation.

  At least one of all devices and methods disclosed in the specification and claimed can be made and carried out without undue experimentation with respect to the present invention. Although the apparatus and method according to the present invention are described in terms of preferred embodiments, those skilled in the art will appreciate that at least one of the apparatus and method can be used without departing from the concept, spirit and scope of the present invention. On the other hand, it can be understood that the present invention can be applied in the steps or order of steps described in this specification. Thus, all similar alternatives and modifications that can be understood by those skilled in the art are considered to fall within the spirit, scope and concept of the invention as defined in the appended claims.

Claims (15)

An elongate flexible element, a elongate flexible element configured to engage a first target tissue portion and a proximal end configured to engage the first target tissue portion A distal end made of
At least one guide member secured to the elongate flexible element, the at least one guide member forming a lumen extending therethrough;
A tissue retraction device comprising a control wire slidably received within the lumen of the at least one guide member,
The elongate flexible element has a first orientation when a control member is disposed within the lumen of the at least one guide member and a second when the control member is not disposed within the lumen of the at least one guide member. A tissue retraction device that moves between postures.   The tissue retractor according to claim 1, wherein the at least one guide member comprises a plurality of guide members attached along the length of the elongate flexible element.   The tissue retractor according to claim 1 or 2, wherein the end of the at least one guide member comprises a cap.   The tissue retraction device according to any one of claims 1 to 3, wherein the elongate flexible element is substantially planar when in the first position.   The tissue retraction device according to any one of claims 1 to 4, wherein the elongate flexible element is curved along a long axis when in the second posture.   The tissue retraction device according to any one of claims 1 to 5, wherein the elongate flexible element comprises a woven mesh.   The tissue retraction device according to any one of claims 1 to 5, wherein the elongated flexible element comprises a parallel element.   The tissue retractor of claim 7, wherein the parallel elements are secured together by the at least one guide member.   The tissue retractor of claim 8, wherein the control wire passes between the parallel elements when disposed within the at least one guide member.   10. The proximal end and the distal end are comprised of one or more tissue anchors selected from tines, forks, hooks, fingers, barbs, loops, and clips. The tissue retraction device described.   The tissue retraction device according to any one of the preceding claims, further comprising at least one ballast secured to the elongate flexible element.   The tissue retractor of claim 11, wherein the stabilizer comprises one or more tissue engaging elements selected from hooks or barbs.   The tissue retraction device according to any one of claims 7 to 9, wherein a part of the parallel element is curved outward from a long axis of the elongated flexible element.   The elongated flexible element comprises a polymer selected from an acrylate-based polymer, a polyurethane-based polymer, a polynorbornene-based polymer, and a polylactide-based polymer. The tissue retraction device according to any one of ˜13.   The structure according to any one of claims 1 to 13, wherein the elongate flexible element is made of a metal or metal alloy selected from platinum, tungsten, titanium, stainless steel, nickel and nickel-titanium alloy. Retreat device.

Images